NCT02299843

Brief Summary

Currently，the "ALPPS" (associating liver partition with portal vein ligation for staged hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a research hot spot. However, the procedure has a high morbidity and mortality rate.Using radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation band in stage I will reduce the incidence of complications（bile leakage, abdominal infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted Liver Partition with Portal vein ligation for staged hepatectomy （RALPPS）.Investigators hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.1 years

First QC Date

November 17, 2014

Last Update Submit

November 30, 2015

Conditions

Hepatocellular Carcinoma

Keywords

RFAALPPShepatectomymorbidity and mortality

Outcome Measures

Primary Outcomes (2)

  • morbidity during perioperation

    complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.

    2 years

  • mortality during perioperation

    2 years

Study Arms (2)

ALPPS

ACTIVE COMPARATOR

Using ALPPS for the the treatment of hepatocellular carcinoma.

Procedure: ALPPS

RALPPS

EXPERIMENTAL

Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I（RALPPS）.Habib 4X was used in RFA.

Procedure: RALPPS

Interventions

RALPPSPROCEDURE

Using radiofrequency ablation assisted ALPPS（RALPPS）instead of in-situ split of liver to form a coagulation band in stage I.Habib 4X was used in RFA.

RALPPS
ALPPSPROCEDURE

Treat the hepatocellular carcinoma with ALPPS.

ALPPS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An insufficient future liver remnant(FLR\<30% in normal hepatic function or FLR\<40% with hepatic cirrhosis or after chemotherapy）
  • Liver function of Child-Pugh Class A or B.
  • Liver Reserve Function：ICG-R15≤10％
  • No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds.

You may not qualify if:

  • Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
  • Main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus.
  • Extrahepatic or lymph node metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kuansheng Ma, Ph.D

    Institute of hepatobiliary surgery,Southwest Hospital

    STUDY DIRECTOR

Central Study Contacts

Jun Yan, Ph.D

CONTACT

+86-23-18502327600yanjun@sina.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
institute of hepatobiliary surgery

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 24, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CN(1)